(b)(4).Concomitant medical products: cat# us157854 m2a-magnum pf cup lot# 868680, cat# x180309 bi-metric/x por nc 9x125 lot# 416780,and cat# 139259 m2a magnum 42-50m lot# 330050.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d4, g3, h2, h3, h4, h6.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned femoral head identified the taper of the device had damage.The outside radius of the device has a wear mark along with scuffing to the polish.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: posterolateral incision with scar tissue and adhesions.Abductors perfectly healed.In joint adverse local tissue was noted, specimen sent and negative for acute inflammation.Doctor was able to dissociate the cold-welded large metal head from trunnion without damaging the trunnion.Trunnion cleaned and dried.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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